Extractable and Leachable Reference Materials

Extractables and leachables are an impurity subset - including plasticisers, antioxidants and PAHs - that can migrate into a dosage form from containers, closure systems, process components or drug delivery systems via chemical transfer.

Toxicological evaluation of any extractable and leachable identified throughout the shelf life of a drug product is essential to ensure the dose does not raise safety concerns, cariogenic or otherwise.

Our high-quality range of reference materials supports your extractable and leachable testing, enabling you to have confidence in the integrity of both your results and products.